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Home > "S" Clinical Trials Conditions > Screening Women at High Genetic Risk for Ovarian Cancer  Screening Women at High Genetic Risk for Ovarian Cancer
Screening Women at High Genetic Risk for Ovarian Cancer
For Condition: ovarian epithelial cancer
Status: Recruiting
Sponsor(s): University College London ,
Synopsis: RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for ovarian cancer. PURPOSE: Screening trial to determine the best procedure to detect ovarian cancer in women who have a high genetic risk for developing ovarian cancer.
Details: OBJECTIVES: - Determine an optimal screening procedure for ovarian cancer, in terms of the most appropriate screening test, criteria for interpretation of results, and screening intervals, in women at high genetic risk for developing ovarian cancer. - Determine the physical morbidity and the resource implications associated with ovarian cancer screening in these women. - Assess the feasibility of screening this high-risk population in terms of compliance rates. OUTLINE: Patients undergo transvaginal ultrasonography of the ovaries (scheduled for the early follicular phase, day 3-6 of the menstrual cycle) and CA 125 measurement annually. Blood samples are collected every 4 months for analysis of CA 125 levels and novel markers. PROJECTED ACCRUAL: A total of 5,000 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: 35 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - First-degree relative (mother, sister, or daughter) of an affected member of a high-risk family defined as one of the following: - Family containing 2 or more individuals with ovarian cancer who are first-degree relatives - Family containing 1 individual with ovarian cancer and 1 individual with breast cancer and under 50 years of age at the time of diagnosis who are first-degree relative - Family containing 1 individual with ovarian cancer and 2 individuals with breast cancer and under 60 years of age at the time of diagnosis who are connected by first-degree relationships - Family containing an affected individual with a mutation of one of the known ovarian cancer predisposing genes - Family containing 3 individuals with colorectal cancer with at least 1 individual under 50 years of age at time of diagnosis and 1 individual with ovarian cancer who are connected by first-degree relationships - Families where affected relatives are related by second-degree relationships through an unaffected intervening male relative who has an affected sister are allowed PATIENT CHARACTERISTICS: Age: - 35 and over Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - No prior bilateral oophorectomy Other: - No concurrent participation in other ovarian cancer screening trials
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesMackay, Study Chair, Institute of Child Health
Saint Bartholomew's Hospital *Recruiting*
London, England, EC1A 7BE
United Kingdom
Recruiting Ian Jacobs 44-020-7601-8261
Institute of Child Health *Recruiting*
London, England, WC1N 1EH
United Kingdom
Recruiting James Mackay 44-20-7679-8099
Additional Information:
Study ID Numbers: CDR0000069292; EU-20044,CRCA-FOCS,UKFOCSS
Study Start Date:
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033488
Other Ovarian Epithelial Cancer Studies:
1. Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery
2. Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
3. LMB-9 Immunotoxin in Treating Patients With Advanced Colon, Breast, Non-small Cell Lung, Bladder, Pancreatic, or Ovarian Cancer
4. Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer
5. Gene Therapy in Treating Patients With Cancer
Related Studies:
Other ovarian epithelial cancer Clinical Trials
Other England Clinical Trials
Other London Clinical Trials
Screening Women at High Genetic Risk for Ovarian Cancer
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